Vinay Prasad, MD, MPH, who was appointed to run the FDA's Center for Biologics Evaluation and Research (CBER) in May, then resigned in late July after he was criticized by right-wing influencer Laura ...

Executives from DIA, Ranjini Prithviraj and Sudip Parikh discuss documents the FDA released that further detail the agency’s implementation plan for its Software Precertification Pilot Program.

CT-155 achieves Phase III success: Boehringer Ingelheim and Click Therapeutics’ digital therapeutic met the primary endpoint in the CONVOKE trial treating the negative symptoms of schizophrenia.

Patent Settlement Overview: GSK, BioNTech, CureVac, and Pfizer resolve US mRNA vaccine patent litigation, enabling global settlement potential after BioNTech’s CureVac acquisition. Financial Terms: ...

FDA approval milestone: Modeyso (dordaviprone) is the first and only treatment approved for recurrent H3 K27M-mutant diffuse midline glioma in patients aged one year and older. Promising clinical ...

SERB expands pediatric oncology portfolio: The $412 million acquisition of Y-mAbs brings Danyelza, the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma, into SERB’s rare ...

Bayer's restructuring aims for $2.3 billion in annual savings by 2026, with significant workforce reductions. Despite layoffs, Bayer's Q2 2025 earnings showed modest growth, driven by Nubeqa and ...

Ajovy becomes the first-and-only calcitonin gene-related peptide agonist approved for pediatric patients aged six to 17 years with episodic migraine who weigh at least 99 lbs.

HHS is winding down mRNA vaccine development, impacting contracts with major pharma companies and resulting in nearly $500 million in cancellations. The decision follows a review of mRNA investments, ...

Pharmaceutical Executive delivers strategic insights for pharma leaders, covering commercialization, market access, R&D, and leadership to drive success.

Despite missing the primary endpoint, SB-01 demonstrated durable clinical improvements and consistent results in the Phase III MODEL trial (NCT05516992), reinforcing its potential as a non-surgical ...

Shelby Buettner is an associate at McDermott Will & Emery. She advises pharma, medical device, and healthcare companies on FDA regulatory and compliance matters.